Senior Manager, CMC Regulatory

Revolution Medicines is seeking a Senior Manager, CMC Regulatory to develop and implement global CMC regulatory strategies. This role will coordinate CMC regulatory activities to support clinical development and marketing approval, requiring a strong understanding of regulatory requirements and the ability to guide CMC teams throughout the drug development process. The position involves collaboration, managing CMC regulatory activities for global clinical trials, preparing regulatory submissions, and assessing changes to clinical trial materials.

Requirements

• BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
• 7+ years of pharmaceutical / biotech drug development experience in CMC development of NCEs / small molecules with 3+ years of CMC regulatory experience.
• Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.)
• Solid knowledge of US and international GMP quality regulations, current industry practices.
• Demonstrated experience in effective collaboration with internal and external stakeholders.
• Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.
• Effective written and verbal communication skills and good interpersonal skills.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities